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Tegretol 400 mg tablets

*
Pharmacy Only: Prescription

  • Company:

    Novartis Ireland Limited

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

  • Active Ingredient(s):

    Carbamazepine

    *Additional information is available within the SPC or upon request to the company

Updated on 26 May 2023

File name

Tegretol Tabs_REG PIL_PF23-0013_Clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 26 May 2023

File name

Tegretol Tabs_REG PIL_PF23-0005_Clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions

Updated on 26 May 2023

File name

Tegretol Tabs 400_REG SPC_May 2023_Clean_IPHA.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 28 March 2022

File name

Tegretol Tabs_REG PIL_PF 21-0277_clean.pdf

Reasons for updating

  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - possible side effects

Updated on 28 March 2022

File name

Tegretol Tabs 400_REG SPC_Mar 2022_Clean_IPHA.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 23 February 2021

File name

Tegretol Tabs_REG PIL_February 2021_Clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - manufacturer

Updated on 23 February 2021

File name

Tegretol Tabs 400_REG SPC_Feb 2021_IPHA.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 09 September 2019

File name

Tegretol_Tablets_REG PIL_PF18-0012_Sept 2019_Clean.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision

Updated on 09 September 2019

File name

Tegretol Tablets 400mg REG SPC PF18-0012_Sept 2019_Clean_IPHA.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 22 January 2019

File name

Tegretol Tablets 1230529_1230530_IE_TA_p3_LFT_X-4 RA approved 07.08.2018 IPHA.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 08 November 2018

File name

Tegretol Tablets 400mg REGSPC Nov 2018_Clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 25 July 2018

File name

Tegretol Tablets 400mg REGSPC July 2018_clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - Marketing authorisation number(s)

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 03 March 2017

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 03 March 2017

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 6.3, the shelf-life has been changed from 1 to 2 years.
In section 6.5, Nature and contents of container description has been updated

Updated on 27 May 2015

File name

PIL_8536_148.pdf

Reasons for updating

  • New PIL for new product

Updated on 27 May 2015

Reasons for updating

  • Change due to user-testing of patient information

Updated on 28 April 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Tablets

Typographical changes have been made to the following Sections of the SmPC:

2, 4.1, 4.2,4.3, 4.4, 4.5, 4.6, 4.7, 4.8, 4.9, 5.1, 5.2, 5.3, 6.5

Updated on 15 May 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The main changes include:

Section 4.2:

A maximum dose is specified in the treatment of trigeminal neuralgia and in epilepsy for children and adolescents.

 

Section 4.4:

Tegretol CDS information on the risk of skin reactions potentially associated with HLA-B*1502 and HLA-A*3101 alleles was reassessed in light of the July 2012 EU PhVWP text. As a result of this analysis, for HLA-A*3101 the existing recommendation for testing at-risk patients is unchanged in the CDS while in EU the testing for this allele cannot be recommended due to insufficient data. The same terminology “allele frequency” is used for both alleles and some frequencies were corrected in some populations.

 

DRESS is described as part of the multi-organ hypersensitivity disorder.

 

Addition of a Warning/Precaution on hyponatremia and hypothyroidism.

 

Section 4.5:

Rifabutin, voriconazole, simvastatin, atorvastatin, lovastatin, cerivastatin and ivabradine are added to the part of the Interactions describing the decrease by Tegretol of the plasma levels of concomitant agents.

 

Section 4.6:

Congenital malformation text is supplemented with data from pregnancy registries, with information on the additional risk in combination with valproate and with information on higher risk with dose of carbamazepine > 400 mg per day in monotherapy.

 

In breast-fed infants, cases of cholestatic hepatitis have been reported and careful observation is recommended.

 

Section 4.7:

Addition of ataxia, diplopia, impaired accommodation and blurred vision as ADR impacting Driving and using machines.

 

Section 4.8:

“Reactivation of human herpesvirus 6 infection”, “bone marrow failure”, “sedation”, “memory impairment”, “colitis”, “lichenoid keratosis”, “onychomadesis”, “fracture” and “bone density decreased” are added as postmarketing ADRs.

 

Preferred terms according to MedDRA version 15.0 are used for the all ADR.

 

Section 4.9:

Cases of rhabdomyolysis and of depressed level of consciousness have been reported. It is specified that hemodialysis is an effective method of treatment for overdosage.

 

Section 5.3:

This section was expanded and rewritten although no new data are available.

Updated on 08 May 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about overdose
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Updated on 02 August 2013

Reasons for updating

  • Change of manufacturer

Updated on 05 July 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 Special warnings and precautions for use:

Information regarding the correlation between SJS/TEN and the presence of HLA-A*3101 was added (e.g.  the correlation between less severe cutaneous reactions, hypersensitivity syndrome and the presence of HLA-A*3101).

General information on the prevalence rates of HLA-A*3101 in different populations was added.

The consideration to test genetically at-risk patients for the presence of HLA-A*3101 before initiating therapy with Tegretol was added.

The limitations of testing was also added.

 

Section 4.5 Interaction with other medicinal products and other forms of interaction:

Ciprofloxacine was added as an agent that may raise carbamazepine level while aprepitant, albendazole, cyclophosphamide, lapatinib, temsirolimus, aripiprazole, paliperidone, tadalafil, tacrolimus and sirolimus were added as agents that may have their plasma levels decreased by carbamazepine.

 

Section 4.8 Undesirable effects:

AGEP and DRESS were added as postmarketing ADR’s.

Updated on 26 February 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 16 November 2012

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.2 the following text has been added: See information on genetic testings and cutaneous reactions in section 4.4

Section 4.4 and 4.8 have been updated to include warnings regarding the risk of Carbamazepine-induced cutaneous reactions - association with HLA-A*3101 allele in European and Japanese patients and update of recommendation on testing for HLA-B*1502 allele in some Asian populations. 


In section 4.8 the following statement has been included: There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long-term therapy with Tegretol.  The mechanism by which Tegretol affects bone metabolism has not been identified.

Section 4.8 has also been updated to include warnings regarding Stevens-Johnson-Syndrome (SJS) and Toxic Epidermal Necrolysis (TEN)

Updated on 25 May 2012

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 6.3 - shelf life reduced from 3 years to 1 year
Section 6.4 - additional storage condition of "Do not store above 25C" included.
Section 6.5 - new packaging component introduced "ALU/PVC/PE/PVDC blister strips with sealable lacquered aluminium foil"

Updated on 24 May 2012

Reasons for updating

  • Change to storage instructions

Updated on 24 June 2010

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes were made to sections 4.4 and 4.8 concerning vanishing bile duct syndrome and changes to section 4.5 re interactions with sertraline, mianserin and buprenorphine.  There was also a warning re increase in SJS, hypogammaglobulineamia added to 4.8 and interactions with paroxetine and levetiracetam added to 4.5 - both resulting from PSUR 5.

Updated on 10 May 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

All sections, i.e. 2, 3, 4.8, 6.1, 6.4, 6.5 and 6.6 were mainly only amended to bring into line with the QRD template wording as a result of the licence renewal application.

Updated on 06 May 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to improve clarity and readability

Updated on 31 July 2009

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.2 - Posology and method of administration

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

In section 4.2 added:

"Before deciding to initiate treatment, patients of Han Chinese and Thai origin should whenever possible be screened for HLA-B*1502 as this allele strongly predicts the risk of severe carbamazepine-associated SJS (See section 4.4)"

In section 4.4 added more detailed information on SJS/TEN skin reactions associated with carbamazepine and the Human Leukocyte Antigen (HLA)-B*1502 allele.

Updated on 27 July 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 26 June 2008

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Changes to Section 4.5,4.8,5.2

Updated on 07 March 2007

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

Legal category:Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

The changes follow a BPI update

Updated on 29 January 2007

Reasons for updating

  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 13 May 2005

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may be renewed (B)

Updated on 12 May 2005

Reasons for updating

  • Change to storage instructions

Updated on 26 August 2004

Reasons for updating

  • New PIL for medicines.ie